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RECRUITING
NCT06584383
NA

A Prospective, Randomized, Controlled Trial to Test Safety and Effectiveness of Unilateral Exablate MR-guided Focused Ultrasound Subthalamotomy in Patients With Early-Stage Parkinson's Disease

Sponsor: InSightec

View on ClinicalTrials.gov

Summary

This prospective, randomized, multicenter study aims to evaluate in Early-Stage Parkinson's Disease (ESPD) patients the safety and effectiveness of treatment with Exablate MRgFUS subthalamotomy vs best medical treatment.

Official title: Early Focus II: A Prospective, Randomized, Controlled Trial to Test Safety and Effectiveness of Unilateral Exablate MR-guided Focused Ultrasound (MRgFUS) Subthalamotomy in Patients With Early-Stage Parkinson's Disease (ESPD)

Key Details

Gender

All

Age Range

30 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2024-08-01

Completion Date

2029-09

Last Updated

2026-02-18

Healthy Volunteers

No

Interventions

PROCEDURE

Exablate MRgFUS subthalamotomy

Exablate MRgFUS subthalamotomy for Parkinson's Disease

DRUG

Best Medical Treatment

Subjects will be managed according to conventional therapeutic guidelines (i.e., best medical treatment) for Parkinson's Disease

Locations (4)

Pontificia Universidad Catolica de Chile

Santiago, Chile

Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH)

Kiel, Germany

HM CINAC- Hospital Universitario HM Puerta del Sur

Móstoles, Spain

Clinica Universidad de Navarra

Pamplona, Spain